BEEFING UP SKINNY LABELS: INDUCED INFRINGEMENT AS A QUESTION OF LAW

The cost of pharmaceuticals has a massive influence on the healthcare system. The global pharmaceutical industry had a revenue of $1.27 trillion in 2020, with revenue of sales in North America accounting for approximately half of that. This colossal market is seen as a burden to many, and a majority...

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Bibliographic Details
Published in:The Notre Dame law review 2022-04, Vol.97 (4), p.1707
Main Author: Potter, Garretl T
Format: Article
Language:English
Subjects:
Analysis
Bench trials
Composition
Copyright infringement
Drug delivery systems
Equity (Law)
Evaluation
Generic drugs
Intent (Law)
Labeling
Law and fact
Laws, regulations and rules
Management
Manufacturers
Patent infringement
Patient package inserts
Pharmaceutical industry
Product development
Proprietary drugs
Revenue
Right to trial by jury
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Summary:The cost of pharmaceuticals has a massive influence on the healthcare system. The global pharmaceutical industry had a revenue of $1.27 trillion in 2020, with revenue of sales in North America accounting for approximately half of that. This colossal market is seen as a burden to many, and a majority of United States citizens shows unified support for decreasing the price of drugs. Government officials from both Democratic and Republican parties have floated plans to decrease the cost of healthcare by incorporating more use of generic drugs which would serve as competition to brand drug manufacturers that otherwise retain a monopoly on the drug market. One way that generic drug manufacturers are able to compete with brand manufacturers is through the use of "skinny labels." Under the Hatch-Waxman Act of 1984, drug manufacturers can introduce a generic version of a pioneer drug to the market so long as any patented methods of use or treatment are "carved out" of the drug label, making it a so-called "skinny label.
ISSN:0745-3515